MAUDE Adverse Event Report: SOFRADIM PRODUCTION SAS MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH; MESH, SURGICAL, POLYMERIC

Model Number	PCO1510OS
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Abdominal Pain (1685); Adhesion(s) (1695); Erosion (1750); Diarrhea (1811); Inflammation (1932); Nausea (1970); Pain (1994); Electrolyte Imbalance (2196); Hernia (2240); Obstruction/Occlusion (2422); Abdominal Distention (2601); Unspecified Tissue Injury (4559); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Type of Reportable Event	Serious Injury
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced pain, inflammation, adhesions, detachment, shrinkage of mesh, erosion, obstruction, recurrence, shrinkage and disengagement of mesh from the inferior and lateral edge of the hernia to the right.Post-operative patient treatment included usage of drain, removal of mesh, medications, and small bowel resection.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The patient¿s attorney alleged a deficiency against the device.The product was used for therapeutic treatment of an incisional hernia.It was reported that after implant, the patient experienced pain, inflammation, adhesions, mesh detachment, shrinkage of mesh, mesh erosion, obstruction, recurrence, disengagement of mesh from the inferior and lateral edge of the hernia to the right, distention, labs abnormal for wbc; magnesium, abdominal pain, diarrhea, leukocytosis, nausea, electrolyte imbalance.Post-operative patient treatment included usage of drain, removal of mesh, medications, small bowel resection and primary anastomosis, ct scan, hospitalization, iv fluids, iv pain medication, anti-nausea medication, npo, electrolytes replenished, diagnostic lap, lysis of adhesions, mesh revision/partial removal of mesh, anesthesia, tap block under ultrasound guidance, hernia repair with mesh.
Additional Manufacturer Narrative
Additional info: h6 (patient codes, ime e2402: labs abnormal for wbc, leukocytosis).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: MESH SOFRADIM - PARIETEX¿ COMPOSITE MESH
• Common Device Name: MESH, SURGICAL, POLYMERIC
• Manufacturer (Section D): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer (Section G): SOFRADIM PRODUCTION SAS; 116 avenue du formans; trevoux 01600 ; FR 01600
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 15577649
• Report Number: 9615742-2022-00947
• Device Sequence Number: 20672466
• Product Code: FTL
• UDI-Device Identifier: 10884521179691
• UDI-Public: 10884521179691
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K110816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2015
• Device Model Number: PCO1510OS
• Device Catalogue Number: PCO1510OS
• Device Lot Number: PKL00485
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/28/2022
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 07/16/2024
• Date Device Manufactured: 12/27/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 36 YR
• Patient Sex: Female
• Patient Weight: 85 KG